Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Running, not enrolling · Phase 3

Conditions studied: Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma

In brief

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Key facts

Study ID

NCT06625320

Run by

Revolution Medicines, Inc.

People needed

500

Starts

2024-10-16

Expected to finish

2027-12-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years old and has provided informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically or cytologically confirmed PDAC with metastatic disease.
• Measurable disease per RECIST 1.1.
• Adequate organ function (bone marrow, liver, kidney, coagulation)
• Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
• Able to take oral medications.

You may not qualify if…

• Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
• History of or known central nervous system metastatic disease.
• Any conditions that may affect the ability to take or absorb study treatment
• Major surgery within 4 weeks prior to randomization.
• Patient is unable or unwilling to comply with protocol-required study visits or procedures

Where it is running

• Mayo Clinic Cancer Center - Phoenix — Phoenix, Arizona, United States
• City of Hope-Duarte — Duarte, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• UC San Diego Health Moores Cancer Center — San Diego, California, United States
• Mission Hall UCSF — San Francisco, California, United States
• Rocky Mountain Cancer — Aurora, Colorado, United States
• Mayo Clinic Cancer Center - Florida — Jacksonville, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Cancer Care Centers of Brevard Inc — Palm Bay, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Cancer Center - Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYU Lagone Health — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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